abstract: Access to anti-cancer drugs: Many evidence-based treatments are off-label and unfunded by the PBS - Australia

Access to anti-cancer drugs: Many evidence-based treatments are off-label and unfunded by the PBS

 ABSTRACT

Background:  The off-label use of a drug refers to a use outside the terms of its approval by the Therapeutic Goods Administration's (TGA). It is also possible to prescribe unlicensed drugs under the Therapeutic Goods Administration's (TGA) Special Access Scheme. A high rate of off-label prescribing has previously been reported in cancer. Our study aimed to document the disparity between clincial evidence-based guidelines for anti-cancer therapy, product approval, and funding status of these agents within an academic tertiary/quaternary cancer centre.

Method:  All chemotherapy protocols approved for use in our specialist oncology centre were assessed to determine if the drugs were off-label or unlicensed for that indication based upon review of their current product information. The Pharmaceutical Benefits Scheme (PBS) funding status for each protocol was subsequently assessed.

Results:  A total of 448 protocols, containing 82 different drugs, across 15 tumour groups were identified. Overall, 189 (42.2%) of protocols were off-label and 3 (0.7%) were unlicensed. This resulted in all 192 protocols being unfunded by the PBS. Of the 189 off-label protocols, 132 (69.9%) were based on established evidence-based treatment guidelines and a further 39 (20.6%) were based upon phase II or III clinical trial data.

Discussion:  Over 90% of off-label protocols are supported by established treatment guidelines or published peer-reviewed research even though the medications are not approved for that particular use by the TGA. However, these off-label protocols are unfunded by the PBS: this results in a marked inequality of access to appropriate medications for cancer patients across Australia.

abstract: Predictors of prescription errors involving anticancer chemotherapy agents (note: carboplatin)

Blogger's note: stats removed for ease of reading

Aim

The majority of medication errors that harm patients relate to the prescribing process. Our study aimed to identify the predictors of prescription errors involving anticancer chemotherapy agents.

Methods

All consecutive antineoplastic prescriptions from June 2006 to May 2008 were analysed, with medication errors being captured. Potential risk factors for medication prescribing errors were defined in relation to the patient, chemotherapy regimen and hospital organisation. The relationship between these risk factors and observed medication errors or dose medication errors was assessed by univariate and multivariate logistic-regression analyses.

Results

Among the 17,150 chemotherapy prescriptions, 540 contained at least one error (3.15%). The following independent predictors of risk of medication errors were identified: patients with a body surface area , protocols with more than three drugs , protocols involving carboplatin, protocols requiring at least one modification by the physician, inpatient care  and prescriptions by a resident physician. The risk of medication dose prescribing errors was significantly associated with three independent factors: protocols involving carboplatin  protocols with more than three drugs and protocols requiring at least one modification.

Conclusion

In this epidemiologic study, the independent risk factors identified should be targeted for preventive measures in order to improve anticancer agent prescriptions and reduce the risk of medication errors.

abstract: Variation and Consternation: Access to Unfunded Cancer Drugs in Canada

".... The majority of respondents felt all methods of accessing unfunded intravenous cancer drugs should be available (76% in their own center; 60% in private clinics) and used these methods to access these medications (81% in their own institution; 62% in private clinics)...."



Conclusion:
Access to effective but unfunded cancer drugs varies across Canada. Policymakers need to consider whether this is consistent with articulated values of the system and whether currently planned processes address these inconsistencies. Key stakeholders need to consider the merits of the different means of accessing these drugs to appropriately and fairly integrate access into publically funded health care systems like that of Canada and other systems like that of the United States, which could face similar limits in the future.

Author Insights: Some Clinical Trials Intended for Drug Marketing, Not Advancing Science « news@JAMA (seeding trials)

Technology Review: Fine-tuning Cancer Treatments

Scientists at the Wellcome Trust Sanger Institute and Massachusetts General Hospital will test 400 compounds, including chemotherapy drugs and molecularly targeted treatments, on 1,000 cancer cell lines containing cancer-related genetic mutations in an effort to advance personalized medicine. The findings are expected to help drugmakers design clinical studies that include only patients who are most likely to benefit from experimental cancer drugs.
 
"...While a number of molecularly targeted cancer drugs, such as gleevec and herceptin, are already on the market, the effectiveness of most of these drugs depends on a single genetic mutation or molecular marker in the tumor. Scientists say that incorporating the diversity of cancer genomics in much greater detail will enable more personalized treatment for a broader number of patients...cont'd

CMAJ: Pan-Canadian review of cancer drugs will not be binding on provinces